WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST After regulators on both sides of the Atlantic revealed probes into Johnson & Johnson’s COVID-19 vaccine, U.S. officials called for an immediate pause. Nearly 7 million shots have been delivered, and six women have been diagnosed with rare blood clots that have a tricky treatment regimen. One died and one is in critical condition. At the same time, a shortage of sterile plastic bags used to grow vaccine cells, at 2,000 liters apiece, has hampered Novavax's work to scale up its own shot—a scarcity the company’s CEO described as a threat to the global vaccine supply. Those stories, plus our top reads of the week, follow below. | |
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Featured Story | By Eric Sagonowsky After drug regulators on both sides of the Atlantic revealed safety probes into Johnson & Johnson’s COVID-19 vaccine, U.S. officials have called for an immediate pause to the rollout. read more |
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Top Stories Of The Week By Arlene Weintraub Researchers at the Massachusetts Institute of Technology and the University of California, San Francisco designed gene editing technology that changes gene expression without damaging DNA. They used it to silence the gene that makes the protein Tau, which has been implicated in Alzheimer’s disease. read more By Conor Hale Outside of unceasing demand for protective equipment, ventilator hardware and diagnostic tests, the COVID-19 pandemic brought many medical procedures to a standstill and slowed the rate of medtech mergers and acquisitions to a crawl. But last summer the dam burst, and money flowed like it could make up for lost time. read more By Eric Sagonowsky AstraZeneca’s COVID-19 vaccine has dominated headlines as reports of rare blood clots mounted, but, now, European drug safety regulators are investigating potential clotting risks from Johnson & Johnson’s vaccine. Like AstraZeneca's, the J&J shot is adenovirus-based. read more By Nick Paul Taylor Sanofi has paid $160 million upfront to buy a preclinical biotech that is using mRNA to reprogram immune cells inside the human body. The technology could enable patients to make their own CAR-T cells, eliminating the complex cell therapy supply chain while improving safety and dosing. read more By Nick Paul Taylor Merck has presented early clinical data on subcutaneous formulations of its blockbuster checkpoint inhibitor Keytruda. The data drop is an early step in an ongoing effort to reformulate Keytruda ahead of the anticipated expiration of U.S. patents in 2028. read more By Ben Adams Thermo Fisher is spending a major $17.4 billion to buy out contract research organization PPD. read more By Nick Paul Taylor Sanofi has posted early-phase data on its recombinant IL-2 molecule in solid tumor patients. Analysts at Jefferies called the data “intriguing” while noting it is currently hard to tell whether the drug improves on the IL-2 pathway agonist Bristol Myers Squibb is developing in partnership with Nektar Therapeutics. read more By Conor Hale By combining artificial intelligence and an extensive atlas of protein biology, Cyclica is taking new approaches to searching for old drugs that could fight COVID-19—and, now, it’s helped find what could become a first-in-class candidate. read more By Kevin Dunleavy With its supply chain straining, Novavax has pushed back supply goals for its COVID-19 vaccine. The company's production push is hindered by a lack of raw materials, CEO Stan Erck said, including sterile plastic bags used to grow vaccine cells. read more By Beth Snyder Bulik Eli Lilly's new chief digital chief hails from Apple. The latest pharma to tap a consumer executive to head digital strategies, Lilly is swapping CDOs amid an accelerated shift to digital spurred by the pandemic. read more Resources Sponsored By: August Bioservices How has COVID-19 impacted CRO/CDMO customer (dis)satisfaction and outsourcing decisions for pharma and biotech companies in 2021 and beyond? Sponsored by: PerkinElmer Informatics Discover the benefits of a cloud-native ELN that delivers better performance, security, connectivity, total cost of ownership PLUS sub-second search results through even the largest data volumes. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored By: OCT Clinical Find out why more than 400 clinical trials annually are initiated in Russia by US and EU pharma in the free annual report by OCT Clinical. Sponsored by: PulsePoint Access this guide for the latest insights into how marketers can use data, technology, and personalized messaging to build vaccine confidence and drive successful immunization efforts. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored By: BC Platforms Those wishing to unlock RWD’s true value must have access to a variety of data sources/types and the technological capabilities to use the data to uncover meaningful insights. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored By: Within3 We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met. Sponsored by: Catalent Hear industry experts discuss the recent advances, challenges and considerations in pediatric drug development. Real-life examples presented by the experts illustrate the impact of age-appropriate dose forms for pediatrics and highlight insights into the caregiver perspectives. Sponsored by: Catalent Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Sponsored by: Catalent Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools. Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. | 